K-number	K233043
Device name	Smart Scope® CX
Applicant	Periwinkle Technologies Pvt., Ltd.
Product code	HEX
Device class	Class II
Decision date	Jun 14, 2024
Decision	Substantially Equivalent
Regulation	884.1630

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Source

View the full FDA submission: accessdata.fda.gov

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Smart Scope® CX

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